Catalog Number

SAN5ABRKR9

Brand Name

CARDINAL HEALTH

Version/Model Number

SAN5ABRKR9

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OIP

Product Code Name

Radiology-diagnostic kit

Public Device Record Key

ed9a2548-2d74-4c7d-af6f-da888151ecab

Public Version Date

September 22, 2022

Public Version Number

1

DI Record Publish Date

September 14, 2022

Package DI Number

50195594832528

Quantity per Package

2

Contains DI Package

10195594832520

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE